Endoscope and method of use

ABSTRACT

Disclosed herein are endoscope assemblies, and more particularly endoscopes with a working channel for use in hysteroscopy, and methods of use thereof. Devices and systems related to an integrated hysteroscopic treatment system including an endoscopic viewing system, a fluid management system, a resecting device and a controller for operating all the systems. Also disclosed are integrated hysteroscopic treatment systems that include an endoscopic viewing system, a fluid management system, a resecting device and a controller for operating all the systems.

RELATED APPLICATION INFORMATION

The present application is a non-provisional of U.S. ProvisionalApplication Nos. 62/571,088 filed on Oct. 11, 2017; 62/572,268 filed onOct. 13, 2017; and 62/573,541 filed on Oct. 17, 2017. This applicationis also related to PCT/US2018/055428 filed on Oct. 11, 2018. Theentirety of each of which are incorporated by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to an integrated hysteroscopic treatmentsystem which includes an endoscopic viewing system, a fluid managementsystem, a resecting device and a controller for operating all thesystems.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional aspects of the invention will become clear from the followingdescription of illustrative embodiments and from the attached drawings,in which:

FIG. 1A is a perspective view of components of a hysteroscopic treatmentsystem corresponding to the invention, including an endoscopic viewingsystem, a fluid management system and a resecting device.

FIG. 1B is a perspective view of the endoscopic viewing system and aschematic view of the fluid management system of FIG. 1A.

FIG. 2A is a perspective view of the endoscopic viewing system of FIG.1B from a different angle.

FIG. 2B is perspective view of the endoscopic viewing system of FIG. 2Ashowing a single-use disposable endoscope component separated from are-usable handle component.

FIG. 3 is a view of a handle component, which shows an electricalconnector that interfaces with a projecting electrical connector of ahub of an endoscope component.

FIG. 4 is perspective view of the endoscopic viewing system of FIG. 2Ashowing a finger-actuated control panel.

FIG. 5 is cut-away side view of the endoscopic viewing system of FIG. 2Ashowing a sterile and non-sterile fields of the components.

FIG. 6A is an enlarged perspective view of the distal end of theendoscope shaft assembly showing a working channel with a distal channelportion in a reduced cross-sectional configuration for introduction intoa patient's body.

FIG. 6B is another view of the distal end of the endoscope shaftassembly of FIG. 6A showing the distal working channel portion in anexpanded cross-sectional configuration when a tool shaft is introducedthough the working channel.

FIG. 7 is another view of the distal end of the endoscope shaft assemblyof FIG. 6B showing image the distal working channel portion in anexpanded cross-sectional sensor and lens stack.

FIG. 8 is a perspective view of a partially disassembled endoscopecomponent of the system of FIGS. 1A-2B showing a dedicated pressuresensing channel and disposable pressure sensor.

FIG. 9A is another perspective view of a partially disassembledendoscope component of the system of FIGS. 1A-2B showing inflow andoutflow channels in a channel housing and a flex circuit coupled to theimage sensor and the pressure sensor.

FIG. 9B is a perspective view similar to that of FIG. 9A with thechannel housing removed to show the inflow and outflow channels in theshaft assembly.

FIG. 10 is a perspective view of components of the fluid managementsystem of FIG. 1A.

FIG. 11 is a perspective view of the handle portion of the resectingdevice of FIG. 1A showing the re-usable handpiece in the hub of thecutting component.

FIG. 12 is a view in the resecting device of FIG. 11 with the cuttingcomponent detached from the handpiece.

FIG. 13 is an enlarged perspective view of the working end of theresecting device of FIGS. 1A and 11 with the inner sleeve separated fromthe outer sleeve showing an aperture arrangement in the outer sleeve.

FIG. 14A is a schematic view of a working end of another resectiondevice similar to that of FIGS. 1A and 11 showing an inner sleeve with acutting window and opposing apertures in a first window-open position.

FIG. 14B is another view similar to that of FIG. 14A showing the innersleeve and cutting window in a second position.

FIG. 14C is a view similar to that of FIGS. 14A-14B showing the innersleeve and cutting window in a third window-closed position.

FIG. 15A illustrates an initial step in a method of using the endoscopecomponent of FIGS. 1A-2B in a hysteroscopy.

FIG. 15B illustrates a subsequent step of the hysteroscopic method ofFIG. 15A wherein a resection device is introduced through the endoscopeshaft which stretches the distal elastomeric portion as shown in FIG. 6Aand the resection device is positioned for removal of a uterine polyp.

FIG. 16A is a side view of a working end of an endoscope shaft similarto that of FIG. 6A except with a distal section that may be articulated,with FIG. 16A showing the endoscope distal section in a first straightconfiguration for trans-cervical introduction.

FIG. 16B is another view of the working end of the endoscope shaft ofFIG. 16A showing the distal section in an articulated configuration foruse following trans-cervical introduction.

FIG. 16C is another view similar to that of FIG. 16B showing the shaftof a resecting device introduced through the working channel in theendoscope shaft.

FIG. 17A is a view of the front side of a tubing cassette for use withthe fluid management system shown in FIGS. 1A, 1B, 10 and 18.

FIG. 17B is a view of the back side of the tubing cassette of FIG. 17Ashowing a transducer membrane.

FIG. 18 is a perspective view of a base unit of carrying the fluidmanagement system as in FIGS. 1A and 10 showing encoder type motorsperistaltic pump roller assemblies.

FIG. 19 is a perspective view of an optical sound of the invention forcoupling the endoscope handle component of FIGS. 2A-2B.

FIG. 20 is a perspective view of another variation of an optical soundsimilar to that of FIG. 19 including irrigation flow channels thereinfor coupling to the fluid management system of FIGS. 1A-1B.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1A illustrates a hysteroscopic treatment system 50 corresponding tothe invention which comprises multiple components including anendoscopic viewing system 100, a fluid management system 105 and aresection device 110 that are all operated by a controller 115 in a baseunit 118 with integrated software algorithms configured to operate allthe systems and subsystems.

More in particular, the endoscopic viewing system 100 of FIGS. 1A, 1B,2A and 2B includes a re-usable handle component 120 with afinger-actuated control pad 122 and a disposable endoscope component 125that carries a distal electronic imaging sensor 128. The fluidmanagement system 105 includes a first peristaltic inflow pump 140A andsecond peristaltic outflow pump 140B, a fluid source 145 and fluidcollection reservoir 148 together with a fluid weight measurementsubsystem. The resection device 110 includes a re-usable handpiece 150with a motor drive 155 and a disposable cutting component 160 forresecting tissue in a hysteroscopic procedure, for example, used forresecting uterine polyps. Each of the systems and subsystems will bedescribed in more detail below.

Endoscopic Viewing System

Referring to FIGS. 1B, 2A and 2B, it can be seen that the endoscopicviewing system 100 includes a handle component 120 and a detachablesingle-use endoscope component 125. The endoscope shaft assembly 162 hasa straight proximal portion 165 that extends about a centrallongitudinal axis 166. The shaft includes a distal tip section 170 thatis offset from the longitudinal axis 166. A shaft transition section 172extends at an angle between the straight proximal shaft portion 165 andthe offset distal tip section 170. The imaging sensor 128 is disposed atthe distal end of the offset tip section 170. As can be seen in FIGS.2A-2B, the endoscope component 125 has a working channel 175 extendingtherethrough which will be described in more detail below. In onevariation, endoscope shaft assembly 162 has a diameter ranging between 4mm and 10 mm with an overall length configured for use in hysteroscopy.More commonly, the shaft diameter is from 5 mm to 6 mm in diameter.

In one variation, the endoscope component 125 has a hub 176 that isadapted for sliding, detachable engagement with the handle component 120as can be best seen in FIG. 2B. The endoscope shaft assembly 162 extendsdistally from the hub 176 and the angled transition section 172 anddistal tip section 170 are oriented in a superior or upward directionrelative to the hub 176. As can be seen in FIG. 2B, the hub 176 carriesa projecting electrical connector 178 that is adapted to couple to amating electrical connector 180 in the handle component 120 that can bebest seen in FIG. 3. In some variations, the endoscope shaft assembly162 may be rotated relative to the hub 176 (not shown in FIGS. 2A-2B).While FIGS. 2A-2B illustrates that the endoscope component 125 isconfigured for axial sliding engagement with the handle component 120,it should be appreciated that the angled pistol grip portion 182 of thehandle component 120 could plug into the endoscope component 125 in adifferent arrangement, such as a male-female threaded connector alignedwith the axis 184 of the angled grip portion 182. As will be describedbelow, the endoscope component 125 comprises a sterile device for use inthe sterile field, while the handle component 120 may not be sterilizedand is typically adapted for use in a non-sterile field. A cable 188extends from the handle to an imaging processor 410, controller 115 andpower source described further below (FIGS. 1A-1B).

As can be seen in FIGS. 1A, 1B and 2B, the endoscope component 125includes fluid inflow tubing 190A and fluid outflow tubing 190B thatcommunicate with the fluid management system 105 which is furtherdescribed below and shown generally in FIGS. 1A-1B. As can be understoodfrom FIGS. 2A and 9A, the endoscope hub 176 can consist of two injectionmolded plastic shell elements 192 a and 192 b, and FIG. 9A shows oneside element removed to the interior of the hub 176. It can be seen thatboth the inflow tubing 190A and outflow tubing 190B are coupled to aninjection-molded flow channel housing 194 in the hub 176 that is fixedto the proximal end 195 of the endoscope shaft assembly 162. FIG. 9B isa cut-away view similar to that of FIG. 9A with the housing 194 removedto show that inflow tubing 190A communicates with an open space or flowchannel 198 extending through the endoscope shaft assembly 162 that isoutward from the thin-wall sleeve 200 that defines the working channel175 therein. The flow channel 198 can also be seen in FIGS. 6A-6B at itsdistal termination 202 in the endoscope shaft assembly 162. As can beunderstood from FIG. 9B, the outflow tubing 190B communicates with aproximal end of sleeve 200 and working channel 175 which also can beseen in FIGS. 6A-6B. In a method of use that will be described below,the endoscope shaft assembly 162 can be navigated through a patient'sendocervical canal with the inflow and outflow pumps 140A and 140 B (seeFIGS. 1A-1B) operating to provide continuous irrigation to the distaltip of the endoscope component 125 together with endoscopic viewing bymeans of the image sensor 128. Such a variation will thus allow fluidinflows through channel 198 and fluid outflows through the workingchannel 175.

Now turning to FIGS. 6A-6B, the endoscope shaft assembly 162 has a smallinsertion profile or configuration that consists of the outer diameterof the shaft assembly which includes the proximal straight section 165,the angled section 172 that is relatively short as will be describedfurther below and the distal section 170 (see FIG. 6A). Of particularinterest, referring to FIG. 6B, the distal portion of the endoscopeshaft assembly 162 includes a working channel portion 175′ that isre-configurable between a first smaller cross-section as shown in FIG.6A for accommodating fluid outflows and a second larger cross-section asshown in FIG. 6B for accommodating a shaft of the resecting device 110(FIG. 1A) or another similar tool shaft.

In one variation shown in FIGS. 2B and 6B, it can be seen that thesleeve 200 that defines the working channel 175 extends in a straightconfiguration through the endoscope component 125 from its proximal end205 to its open distal termination 208. As can be seen in FIGS. 6A and6B, the distal end 212 of sleeve 200 has a superior surface 214 that isstraight and rigid. The working channel sleeve 200 has an inferior orlower sleeve portion 215 that is flexible and in one variation has aliving hinge portion 218 below sidewall cut-outs 220 a and 220 b in thesleeve 200. Further, the distal end of the endoscope component 125includes an elastomeric sleeve 225 that surrounds the angled shaftportion 172 and the distal shaft section 170 as well as a distal portionof the proximal straight shaft 165. Thus, as can be seen in FIG. 6A, theelastomeric sleeve 225 has sufficient elastic strength to collapse orconstrict the working channel portion 175′ to the smaller cross-sectionas seen in FIG. 6A.

As can be seen in FIG. 6A, the lower sleeve portion 215 includes asleeve wall 226 with sufficient curvature to maintain an open pathwaythrough the working channel 175 when the elastomeric sleeve 225constricts the working channel portion 175′ which thereby alwaysprovides an open fluid outflow pathway. For example, the sleeve wall 226can have the diameter as a proximal portion of sleeve 200 and extendover a radial angle ranging from 30° to 90°. While the lower sleeveportion 215 shown in FIG. 6A comprises a portion of the wall of metalsleeve 200, in another variation, the flexible lower sleeve portion 215may be any bendable plastic material or a combination of plastic andmetal.

FIG. 6B next shows the working channel portion 175′ in its secondexpanded configuration as when a physician inserts an elongated toolshaft 230 (phantom view) through the working channel 175. Such a toolshaft 230 will initially slide along the hinge portion 218 of the lowersleeve portion 215 and then stretch the elastomeric sleeve 225 to opendistal working channel portion 175′ to allow the tool shaft 230 toextend through the working channel. In other words, the elastomericsleeve 225 will be stretched or deformed to a tensioned position asshown in FIG. 6B as a tool shaft 230 is inserted through the distalworking channel portion 175′. When the tool shaft 230 is withdrawn fromthe working channel portion 175′, the elastomeric sleeve 225 will returnfrom the tensioned position of FIG. 6B to the repose or non-tensionedposition of FIG. 6A to return the working channel portion 175′ to theconstricted configuration FIG. 6A.

In general, the endoscope component 125 corresponding to the inventionallows for the use of an image sensor 128 having a large diagonaldimension relative to the insertion profile or diameter of the endoscopeshaft assembly 162 while at the same time providing a working channel175 that has a large working channel diameter WCD relative to theinsertion profile or diameter of the endoscope shaft assembly 162. Morein particular, the endoscope component 125 comprises a shaft assembly162 having a shaft diameter SD extending to a distal shaft section 170,an image sensor 128 with a diagonal dimension DD carried by the distalshaft section 170 and a working channel 175 having a diameter WCDextending through the shaft assembly 162, wherein the working channelportion 175′ in the distal end of the shaft assembly 162 is adjustablein shape to accommodate a tool shaft introduced therethrough and whereinthe combination of the sensor's diagonal dimension DD and the workingchannel diameter WCD is greater than the shaft diameter SD (see FIG.6B). In a variation, the sensor diagonal dimension DD is greater than50% of the shaft diameter SD or greater than 60% of the shaft diameter.In a variation, the working channel diameter WCD is greater than 30% ofthe shaft diameter, greater than 40% of the shaft diameter or greaterthan 50% of the shaft diameter. In other words, the working channelportion 175′ in the distal end is adjustable between a firstcross-sectional dimension and a second cross-section dimension. In thevariation of FIGS. 6A-6B, the working channel portion 175′ in the distalregion of the endoscope shaft assembly 162 is adjustable between an apartially constricted shape and a non-constricted shape.

In one variation, referring to FIG. 6A, the distal section 170 of theendoscope shaft assembly 162 has an axial dimension D1 ranging from 5 mmto 20 mm. Also referring to FIG. 6A, the angled shaft section 172extends over a similar axial dimension D2 ranging from 5 mm to 20 mm.Still referring to FIG. 6A, the central axis 235 of distal shaft section170 can be parallel to and offset from the longitudinal axis 166 of thestraight shaft section 165 by a distance ranging from 1 mm to 8 mm.

Now turning to FIG. 7, the image sensor 128 is carried in a housing 236that also carries a lens assembly 240 as is known in the art. The sensorand lens housing 236 is then carried in a thin wall sleeve 238 thatcomprises the distal endoscope section 170. Further, one or more lightemitters, for example, LEDs indicated 244A and 244B carried on eitherside of the image sensor housing 236. Of particular interest, thedistalmost surface 245 of the lens assembly 240 and the LEDs 244A and244B is disposed distally outward from the distal end 246 of thethin-wall sleeve 238 as shown in FIG. 7. It has been found thatproviding such a distalmost surface 245 of the lens assembly and theLEDs outwardly from the shaft sleeve 238 improves lighting from the LEDs244A and 244B as well as improving the field of view of the image sensor128. The distance indicated at D3 in FIG. 7 can range from 0.2 mm to 2.0mm.

Now referring to FIGS. 7 and 8, another aspect of the inventioncomprises a dedicated fluid pressure sensing channel 250 that extendsthrough a thin wall sleeve 252 in the endoscope shaft assembly 162. Ascan be seen in FIGS. 6A-6B, the distal end 254 of the pressure sensingsleeve 252 is open in the distal surface of the endoscope component 125.Referring to FIG. 8, the proximal end 256 of the pressure sensingchannel 250 extends to the housing 194 in the hub 176 to communicatewith a disposable pressure sensor 270. The pressure sensor 270 haselectrical leads coupled thereto through the electrical connector 178 inhub 176 to thereby send electrical signals indicating pressure to thecontroller 115 (FIG. 1A) as will be described further below. Thus, inone aspect, the disposable endoscope component carries a single-usepressure sensor 270 coupled by a detachable connector to a remotecontroller 115.

In one variation, referring to FIG. 8, the thin wall sleeve 252 consistsof a hydrophobic material, which can be any suitable polymer such asPFTE, having an interior diameter ranging from 0.25 mm to 2.5 mm. Often,the inner diameter of the thin wall sleeve 252 is between 0.5 mm and 1.5mm. It has been found that a hydrophobic surface in the pressure sensingchannel 250 will prevent the migration of fluid into the channel andthereby trap an air column in the channel communicating with thepressure sensor 270. The compressibility of the air column in thepressure sensing channel 250 is not significantly affect the sensedpressure since the channel diameter is very small. In another variation,the metal sleeve 252 can be coated with a hydrophobic surface or anultrahydrophobic surface.

Now turning to FIGS. 6A and 9B, the image sensor 128 and LEDs 244A and244B are connected to an elongated flex circuit 275 that extends fromelectrical connector 178 in hub 176 through the endoscope shaft assembly162. It has been found that only a flex circuit 275 is capable ofcarrying a sufficient number of electrical leads to the image sensor128, the LEDs and the pressure sensor 270 to provide for systemoperation, wherein the number of electrical leads can range from 10 to100. Further, the flex circuit 275 can extend through the shaft assembly162 with an interior space that also function as the fluid flow channelsince the flex circuit 275 adequately insulates all the electricalleads.

Handle Component of the Endoscopic Viewing System

Now referring to FIGS. 2B and 3, it can be seen that the handlecomponent 120 has an angled pistol grip portion 182 with an axis 184that is angled from 10° to 90° away from the longitudinal axis 166 ofthe endoscope's proximal shaft portion 165. The grip portion 182includes a control pad 122 that carries actuator buttons for operatingall the functions of the treatment system, for example, including (i)operating the fluid management system 105, (ii) capturing images orvideos from sensor 128, (iii) adjusting light intensity from the LEDs244A and 244B, etc. The interior of the handle component 120 also cancarry an image processor. or such an image processor may be located inthe control unit or base unit 118 shown in FIG. 1A.

FIG. 3 is a view of the handle component 120 from a different anglewhich shows the electrical connector 180 that interfaces with theprojecting electrical connector 178 of the hub 176 of the endoscopecomponent 125. FIG. 3 further shows receiving channels 288 a and 288Bthat receive projecting rail elements 290 a and 290 b of the endoscopehub 176 as can be seen in FIG. 2B. In FIG. 3, it also can be seen thatthe grip portion 182 has a recessed channel 295 therein that is adaptedto receive and lock in place the inflow and outflow tubing 190A and 190Bso as to integrate the tubing set with the pistol grip 182 during use.This feature is important so that the inflow and outflow tubing will notinterfere with operation of the endoscope component 125 or the resectingdevice 110 introduced through the working channel 175 as will bedescribed in more detail below.

Now turning to FIG. 4, the enlarged view of the assembled handlecomponent 120 and endoscope component 125 shows the control pad 122 withfour actuator buttons or switches which are adapted to operate thesystem. In one variation, actuator 302 is adapted for turning on and offirrigation, or in other words actuating the fluid management system 105as will be described further below. Actuator 304 is adapted for image orvideo capture. In a variation, momentary pressing the actuator 304 willcapture a single image and longer pressure on the actuator will operatea video recording.

Actuator or scrolling button 306 has a scrolling function, whereinpressing the scrolling button 306 will cycle through various subsystemsthat then can be further adjusted by the central button or up/downactuator 310, which is adapted for increasing, decreasing or otherwisechanging an operating parameter of any selected subsystem. In oneexample, the scrolling button 306 can be actuated to cycle through thefollowing subsystems and features: (i) fluid inflow/outflow rate fromthe fluid management system 105; (ii) the set pressure which is to bemaintained by fluid management system 105; (iii) fluid deficit alarmwhich is calculated by the fluid management system 105; (iv) optionalselection of still image capture or video capture, and (v) LED lightintensity. Then, the physician can activate the central up/down actuator310 to adjust an operating parameter of the selected subsystem. As willbe described further below, the selection of subsystems as well as thereal-time operating parameters of each subsystem will be displayed on avideo monitor or display 320 as shown in FIG. 1A. Thus, it can beunderstood that the physician may operate the scrolling button 306 toscroll through and select any subsystem or feature while observing suchas selection on the display 320, and then actuate the up/down actuator310 can adjust an operating parameter which also can be observed on thedisplay 320.

In another aspect of the invention, the controller 115 includes acontrol algorithm for operating the control pad 122 which provides ajump back to a default condition after the scroll button or actuator 306has been used by the physician. For example, there is a defaultcondition in which a selected subsystem is actuatable by the centralup/down actuator 310. In one variation, the default subsystem is thefluid inflow/outflow rate, which may be the most commonly usedsubsystems that will be actuated by the physician to control fluid flowinto and out of the working space. Thereafter, as described above, thephysician may use the scrolling button 306 to select another subsystemfor adjustment of an operating parameter. If, however, the physiciandoes not continue to scroll between the various subsystems for apredetermined amount of time, then the control algorithm will jump backto the default subsystem, which may be the fluid inflow/outflow rate.The predetermined amount of time, or timeout, with the control algorithmto jump back to the default condition may be anywhere from 1 second to10 seconds, more often between 2 seconds and 5 seconds.

Now turning to FIG. 5, a schematic side view of the assembly of thehandle component 120 with endoscope component 125 is shown to illustratethe sterile field 315 and the non-sterile field 322 relative to theendoscope assembly. As can be understood, the disposable endoscopecomponent 125 is sterilized and the physician or nurse would remove thecomponent 125 from sterile packaging which would then define a sterilefield 315. The endoscope component 125 then would be mated with thehandle component 120 which defines the non-sterile field 322. In othervariations (not shown), a plastic film or other plastic housing couldcover the handle portion 120. FIG. 5 further illustrates a method thatwould be employed by the physician to insert an elongated tool shaft 328into the working channel 175 in a manner that would insure the sterilityof the tool shaft 328. As can be seen in FIGS. 2A, 2B, 4 and 5, thesuperior surface 332 of the hub 176 includes a trough or recessed saddle340 in which the physician can initiate contact with the tool shaft 328which is indicated by an arrow in FIG. 5 and is numbered as step 1.Thereafter, as indicated by an arrow as step 2, the tool shaft 328 canbe guided downward from the saddle 340 into the cone-shaped recess 344in hub 176 which tapers distally to transition into the open proximalend 205 of the working channel 175. Thereafter, the physician can movethe tool shaft 328 axially over the surface of the cone-shaped recess344 and into and through the working channel 175. By using this method,the physician can be assured that the tool shaft 328 will not contactthe non-sterile field 322. In FIGS. 4 and 5, it can be seen that theproximal slanted surface 348 of the hub 176 is substantially in the sameplane P (FIG. 4) as the surface 349 of the angled grip portion 182. Itshould be appreciated that a slanted surface 348′ of the hub 176 can beprovided in a plane outward from the surface 349 of the grip 182 toprovide further assurance that the tool shaft 328 will not contact thenon-sterile field 322.

Base Unit and Fluid Management System

Now turning to FIGS. 1A and 10, the fluid management system 105 can bedescribed in more detail. A rolling stand assembly 400 is provided whichincludes a base 402 with wheels 404 and a vertical pole assemblyindicated at 405. The video display 320 is mounted at the top of thepole assembly 405. A controller base unit or base station 118 isattached to the pole assembly 405 which comprises a housing whichcontains the system controller 115, a video processor 410 and a 3-phasemotor controller/power supply 415 for the resecting device 110 in thismotor drive. Further, the base unit 118 carries the inflow and outflowperistaltic pumps 140A and 140B. The controller 115, as the term is usedherein, includes processors or controller components for operating thefluid management system 105, the resecting device 110 and all aspects ofthe endoscopic viewing system 100. The base unit 118 also contains powersupplies from the resecting device 110, the fluid management system 105and the endoscopic viewing system 100.

As can be seen in FIG. 10, the base unit 118 is carried by a bracket 418that secures the unit to the pole assembly 405. A fluid source, such asa 1 liter saline bag 145 is hung from a first hook 422 a on the inferiorsurface 425 of the base unit 118. Further, another saline bag orcollection reservoir 148 hangs from a second hook 422 b on the inferiorsurface 425 of the base unit 118 for collecting fluid outflows.

FIGS. 1B and 10 further show a cassette 440 that carries first andsecond tubing loops 442 a and 442 b that are adapted to engage theroller assemblies of inflow and outflow pumps 140A and 140B. Thecassette 440 shown in FIG. 10 includes a transducer membrane 444 (FIG.1B) as is known in the art for interfacing with a pressure sensor andthe surface of the control unit 118 that is engaged after the cassette440 is locked in place.

In FIGS. 1A and 10, it can be seen that the inflow pump 140A pumps fluidthrough inflow tubing 190A to the endoscopic viewing component 100. FIG.10 illustrates that a portion of the inflow tubing indicated at 190A′extends from the fluid source 145 to the tubing loop 442 a in thecassette 440 that engages the inflow peristaltic pump 140A. The proximalend 448 of the inflow tubing portion 190A′ as a spike for spiking thesaline bag or fluid source 145 as is known in the art.

In FIGS. 1A and 10, it can be further seen that the outflow tubing 190Bextends from the endoscopic viewing system 100 to the tubing loop 442 bin the cassette 440 that engages the outflow peristaltic pump 140B.Beyond the tubing loop 442 b in the cassette 440, an outflow tubingportion indicated at 190B′ drops downward to a tissue trap 452 wheretissue chips are filtered from the fluid outflow in collected. A secondoutflow tubing portion indicated that 190B″ then extends upward to thecollection reservoir 148.

Referring again to FIG. 10, the system includes at least one load sensorfor providing weight signals to the controller indicating either theweight of the fluid in the inflow source 145 or the weight of the fluidin the collection reservoir 148 or the weight of the combined fluidinflow source 145 and collection reservoir 148. In one variation shownin FIG. 10, the first load cell 455 a is shown which weighs fluid inflowsource 145 and the second load cell 455 b weighs the fluid collectionreservoir. The controller 115 then can receive signals from the two loadcells 455 a and 455 b to calculate the fluid loss. Further, the signalcan be provided when a certain predetermined fluid loss has beenobserved. Also, the controller 115 can provide an alarm signal when theload cell 455 a which weighs the fluid source 145 determines that thefluid source is rated a lower level, which may indicate that anadditional saline bag be connected to the fluid management system.

Still referring to FIG. 10, in another variation, the weight managementsystem can use a load cell 460 and the pole assembly 405 whereintelescoping shaft 462 can carry the weight of both the fluid inflowsource 145 and the collection reservoir 148. The load cell 460 can beused to weigh the assembly and calculate the fluid deficit.

In another aspect of the invention, referring to FIG. 10, the base unit118 is designed for use in a physician's office in therefore should becompact. In one variation the height of the base unit 118 is less than18 inches, the width is less than 12 inches and the depth is less than12 inches. Further, it has been found that the electrical interferencecaused by the 3-phase motor controller/power source 415 controller issubstantial in the sensitivity of the video processor 410 issignificant. Therefore, extensive electromagnetic shielding or EMshielding 488 is required between the 3-phase motor controller/powersource and the video processor 410. In general, one aspect of theinvention comprises providing a video processor within less than 12inches from a three phase motor power source and controller. In othervariations, video processor is less than 8 inches, or less than 6 inchesfrom the 3-phase motor controller/power source.

In general, as shown in FIG. 10, the base unit 118 includes a fluidmanagement system 105 including inflow and outflow peristaltic pumps140A and 140B, a cassette 440 carrying inflow and outflow tubing loopsfor engaging the inflow and outflow pumps, a coupled to the base unit118 are a fluid source 145 comprising a first saline bag and acollection reservoir 148 comprising second saline bag. Further, the baseunit 118 carries at least one load sensor intermediate the base unithousing and the first and second saline bag for weighing either or bothof the first and second saline bags. A digital readout of the weight ofeither or both of the saline bag as is provided on the monitor 320 (FIG.1A) for observation in the recording by the physician or nurse. By thismeans, the fluid deficit can be calculated.

In another variation, the inflow and outflow pumps of the fluidmanagement system utilize encoder-type motors which can send signalsrelating to rotation to the controller 115. By this means, thecontroller 115 can calculate the volume of fluid inflows provided by apump 140A into the working space in the patient's body. Thus, fluidinflows can be calculated either by a load cell or by signals from anencoder-type motor to the controller 115.

Tissue Resecting Device

Now referring to FIGS. 1A, 11 and 12, the tissue resection device 110comprises a re-usable handpiece 150 that carries a motor drive 155together with the detachable cutting component 160. An electrical powercable 502 extends from the handpiece 150 to a the 3-phase motorcontroller/power supply in the base unit 118. As can be seen in FIG. 11,the handpiece 150 has a housing 505 with a channel 508 in lower portionthereof to receive and lock therein the outflow tubing portion indicatedat 512. In FIG. 1A, it can be seen that outflow tubing 512 extends to abranch connector 515 that couples tubing 512 to the outflow tubing 190Bextending back to the outflow peristaltic pump 140B in the base unit118. The outflow tubing 512 as shown in FIG. 1A has a pinch valve 518for closing off the outflow tubing 512. In FIG. 1A, it can be understoodthat the primary outflow tubing 190B extends to the endoscopic viewingsystem 100 through the branch connector 515 into tubing portion 520 tothe hub 176 of the endoscope component 125 as described above. Thus, theendoscopic viewing assembly 100 can be used for both inflows andoutflows during insertion of the endoscope shaft assembly 162 into thepatient, with the pinch valve 518 closing off the outflow tubing 512since the resecting device 110 is not yet in use (FIG. 1A). After theendoscope shaft assembly 162 has been navigated to a working space in apatient's body, and the resecting device 110 has been introduced throughthe working channel 175 of the endoscope component 125, the pinch valve518 can be opened so that fluid outflows are provided through theresecting device 110 rather than through the working channel 175 of theendoscope component 125.

Now turning to FIG. 12, it can be seen that the cutting component 160has a proximal hub 540 that is adapted for detachably coupling to thehandpiece 150. An elongated shaft assembly 545 extends distally from thehub 540 to a working end 548 (FIG. 1A). In one variation, elongatedshaft assembly 545 comprises an outer sleeve 550 with a distal window562 and a rotating inner sleeve 555 with a window 558 (FIG. 13). Such atype of tubular cutter is known in the art wherein the rotating innersleeve 555 cuts tissue that interfaces with window 562 in the outersleeve 550 as the inner sleeve window 558 with teeth 560 rotates at highspeed.

As can be seen in FIGS. 11 and 12, the hub 540 of the resectingcomponent 160 is coupled to a rotating collar 570 which is fixed to theshaft assembly 545 so that the physician can rotate the shaft assembly545 and working end 548 to any rotational orientation for cutting tissuewhile maintaining the handpiece 150 in an upright position. Thehandpiece 150 includes an actuator button 575 for actuating the motordrive 155 to rotate the inner sleeve 555 relative to the outer sleeve550 to thereby cut tissue.

Referring to FIG. 12, the tissue resecting device 110 can have a shaftassembly 545 with a diameter ranging from 2 mm to 6 mm, in is more oftenbetween 3 mm and 5 mm. The shaft 545 has a diameter and length forcooperating with the working channel 175 of the endoscopic viewingsystem 100 as shown in FIG. 1A.

Now turning to FIG. 13, the distal working end 548 of the cuttingcomponent, and more particularly, the outer and inner sleeves, 550 and555, are shown separated to show particular features that correspond tothe invention. In FIG. 13, it can be seen that the outer sleeve 550 isin has an aperture arrangement or opening 572 in the surface thatopposes the window 562. Typically, in a high-speed rotating tubularcutter that is used in hysteroscopy with a fluid management system, themotor controller includes algorithms for stopping rotation of the innersleeve 555 relative to the outer sleeve 550 so that the windows 558 and562 are aligned when the inner sleeve 555 stopped rotating. In suchprior art devices, various sensors and mechanisms have been developed tostop rotation of the inner sleeve 555 in a predetermined position withthe inner and outer windows 558, 562 being oriented to be at leastpartially aligned and open. Such algorithms are complex and may notfunction reliably in all operating environments. The reason for needingsuch a controller algorithm for stopping rotation of the inner sleeve555 with windows 558 and 562 aligned is to ensure that the fluidmanagement system continues to operate to maintain a set pressure in thebody cavity when the resecting device is (i) operating at high speed or(ii) when the resecting device is paused in operation. The controlalgorithms of the fluid management system for maintaining a set pressurein a body cavity typically use a PID controller or a feedback controlsystem as is known in the art. During operation of a resecting devicewith a rotating inner sleeve as shown in FIG. 13, the fluid managementsystem controller can continuously monitor fluid outflows through thewindows 558 and 562 when aligned since the sleeves are only in awindow-closed position for a very brief interval as the inner sleeve 555rotates. The stop algorithm is then used to stop rotation of the innersleeve 555 in a window-open position and the controller again willmonitor continuous fluid flows through the system to maintain the setpressure. However, if the inner sleeve 555 stopped rotating in awindow-closed position, the actual pressure in the body cavity wouldimmediately increase and the control algorithm could react by slowing orstopping the pumps but with no fluid outflows in the window-closedposition, the PID controller could not operate which could increaseactual pressure in the body cavity to an unsafe level or causesignificant fluctuations in pressure in the working space when theresecting device is re-activated to provide fluid outflows.

In one aspect of the present invention, an opening or aperturearrangement 572 is disposed in a wall of outer sleeve 550 opposing theopen window 562. In general, the opening 572 allows for outflows throughthe lumen 574 in the inner sleeve when it stops in the window closedposition. Thus, providing an outflow opening 572 in the outer sleeveallows the fluid management control system and PID feedback controllerto operate and maintain the set pressure no matter whether the innersleeve 555 is stopped in a window-open position or window-closedposition or any intermediate position. In order to provide adequate flowthrough the outflow opening 572 in the window-closed position, it hasbeen found that the area of opening 572 should be at least 10% of thearea of window 562 in outer sleeve and more often at least 20% of thearea of the window 562 in outer sleeve 555. In a variation, the area ofopening 572 is at least 30% of the area of window 562 in outer sleeve555. In FIG. 13, the opening 572 in the outer sleeve 550 is shown as asingle elongated shape, but it should be appreciated that the openingcan comprise a plurality of openings which can be any shape such aselongated slot or slots, an oval shape, round openings or the like.

Now turning to FIGS. 14A to 14C, another variation of working end 578 isshown that is adapted to solve the same problem as the variation of FIG.13. FIGS. 14A-14C are schematic views of a working end 578 of a tubularcutter with the outer sleeve 580 having window 582 therein. The innersleeve 585 has cutting window 588 that for convenience is shown withoutcutting teeth. In this variation, it can be seen that inner sleeve 585has a plurality of outflow openings 590 therein that extendlongitudinally and are space apart around wall of the inner sleeve 585opposing window 588. In this variation, the aperture arrangement canhave from 1 to 20 or more openings. Again, it can be seen in FIG. 14Cthat when the working end 578 is in the window-closed position, theoutflow openings 590 will still allow for fluid outflows through theinterior channel 592 of the inner sleeve 585 to ensure that the PIDcontroller or other control system still can function properly sincethere is a fluid flow through the device. The area of the apertures oropenings again is greater than 10% of the outer sleeve window, greaterthan 20% or greater than 30% of the area of the window 582 in the outersleeve 580.

In another aspect of the invention, the resecting device 110 comprises atubular cutter wherein a windowed inner sleeve rotates relative to theouter sleeve between window-open in window-closed positions, and whereina cooperating fluid management system provides of fluid outflows througha central channel in the tubular cutter and wherein the fluid outflow inthe window-closed position is at least 10% of the fluid outflow throughthe tubular cutter in the window-open position under the same fluidmanagement settings. Again, the fluid outflows in the window-closedposition are provided through at least one aperture or opening in eitherthe outer sleeve, the inner sleeve or combination of both the inner andouter sleeves. In another variation the fluid outflows in thewindow-closed position is at least 20% at least 30% of fluid outflows inthe window-open position.

FIG. 15A illustrates a variation of a method to carry out a plannedhysteroscopic procedure, such as a tissue resection procedure which isshown as a polypectomy. In FIG. 15A, the patient's uterus 602 anduterine cavity 605 are shown with a polyp 608 therein. The cervicalcanal is indicated at 610. Initially, the physician connects theendoscope component 125 to the handle component 120 and then couples theinflow and outflow tubing 190A and 190B to the endoscope component 125(see FIGS. 2A and 2B). Thereafter, the physician can actuate the fluidmanagement system 105 to provide a fluid inflow through the endoscopeshaft assembly 162 as well as outflows through the working channel 175in the shaft assembly. The fluid management system 105 then will providea circulating flow through the patient's cervical canal 610 and uterinecavity 605 and will also maintain a set fluid pressure in the uterinecavity after it is filled with distension fluid.

Thereafter, the distal tip 615 of the endoscope component 125 isintroduced into and through the cervical canal 610. In FIG. 15A, it canbe understood that the offset tip section 170 of the endoscope shaftassembly 162 can be introduced through the cervical canal 610 and thetissue will deform around the tip section 170 and angled section 172such that dilation of the endocervical canal 610 beyond the diameter ofthe shaft assembly 162 is not required.

In FIG. 15B, the distal tip 615 of the endoscope shaft assembly 162 isdisposed within the uterine cavity 605. As can be seen in FIG. 15B, theintroduction of the shaft 545 of the cutting component 160 (FIG. 12)through the working channel 175 in the endoscope causes the distalportion of the working channel 175 to open and stretch the elastomericsleeve to 225 as shown in FIG. 6B to thus provide a straight passagewaythrough the endoscope shaft assembly 162 and into the uterine cavity605. Thereafter, the endoscope shaft assembly 162 can be moved axiallyinward and outward in the uterine cavity 605 and also angled from sideto side. FIG. 15B then shows the working end 548 of the cuttingcomponent 160 (see FIG. 1A) positioned near the polyp 608 ready toactivate rotation of the inner sleeve 555 of the cutter to resect thepolyp (see FIG. 13). FIG. 15B also illustrates that the field of viewFOV of the image sensor 128 and lens assembly 240 is oriented so thatthe working end 548 of the resection device 110 is central in such afield of view FOV.

As can be understood from FIG. 15B, the short axial length of the distalendoscope tip section 170 and angled section 172 allows for the shaftassembly 162 to be moved proximally in the cervical canal 610 and thuswill allow the tip of the resection device to cut tissue very close tothe internal os 626 of the uterine cavity 605.

Now turning to FIGS. 16A-16C, another variation of the working end 650of an endoscope similar to the endoscope component 125 of FIG. 2B isshown. The working end 650 consists of a deflectable tip portion 655that provides for a straight configuration shown in FIG. 16A forintroduction through the cervical canal 610 (see FIG. 15A) andthereafter can be articulated to a deflected shape that has aconfiguration which is the same as the “offset” shape of the working endas shown FIGS. 6A-6B. In FIG. 16 A, it can be seen that an outer sleeve660 is slotted with first and second slots 662 a and 662 b that allowfor deflection of the tip portion 655. Such slotted tube arrangementsfor the deflection of tubular members are known in the art. In thisvariation, the distal deflecting portion 655 is adapted to move from thestraight shape of FIG. 16A to the deflected shape of FIG. 16B by theproximal movement of the working channel sleeve 670. The working channelsleeve 670 has a passageway 672 therein which is similar to thevariation shown in FIGS. 6A-6B. An elastomeric sleeve 675 encases thedistal tip portion 655 as described previously. FIG. 16C shows aninstrument shaft 678 introduced through the passageway 672 whichstretches the elastomeric sleeve 675 around the passageway 672 asdescribed previously and as illustrated in FIG. 16B.

Thus, one aspect of the invention comprises an elongated sleeve assemblywith a working end and an image sensor, wherein a distal portion of theelongated sleeve comprises a slotted outer tube 660 which can bearticulated from a straight position to a deflected position and whereinthe actuation member for articulating the distal outer sleeve portioncomprises a non-slotted inner working channel sleeve 670 that can bemoved axially relative to the slotted outer sleeve 660.

Now turning to FIGS. 17A, 17B and 18, a cassette 440 of the fluidmanagement system 105 of FIG. 10 is shown in more detail. FIG. 17A showsthe cassette 440 from the front side 680 and FIG. 17B shows the cassettefrom the back side 682 that interfaces with the peristaltic pumps 140Aand 140B (FIGS. 10 and 18). The cassette housing 685 comprises a singleinjection molded part which greatly reduces the cost of manufacturing.It can be seen that the first tubing loop 442 a is adapted for engagingthe inflow pump 140A as also shown in FIG. 18. The second tubing loop442 b in cassette 440 engages the outflow pump 140B. In FIG. 17B, it canbe seen that cassette 440 carries a the thin flexible membrane 688 influid communication with tubing loop 442 a which functions as atransducer that interfaces with a pressure sensor on the front surface690 of the base unit 118 (see FIGS. 10 and 18). Thus, the sensedpressure in the inflow line can signal the controller 115 to modulatethe inflow and outflow pumps to thereby maintain a set pressure in theuterine cavity. It should be appreciated that a second similartransducer (not shown) can be provided in the cassette 440 tocommunicate with second tubing loop 442 b and an other pressure sensorin base unit 118 to sense pressure in the outflow line 190B which couldbe used as an additional pressure signal for controlling the setpressure.

FIG. 18 is an enlarged view of the base unit 118 and the cassette 440.In one variation, the cassette can be manually pushed into place overthe inflow and outflow pumps 140A and 140B and then manually locked inplace. In another variation, a motor unit (not shown) in the base unitcan be used to engage and move the cassette 440 into position over theinflow and outflow pumps and to lock the cassette in place. Anadditional sensor, such as the Hall sensor in the base unit 118, candetect a magnet in the cassette 440 to provide a signal that thecassette is locked in place. Other types of sensors such asmicroswitches can be used to sense the cassette 440 being locked inplace. In another variation, the cassette 440 and the base unit 118 canbe configured with cooperating RFID components to identify theparticular cassette that is used and thereafter the controller 115 canoperate a particular set of algorithms for maintaining a set pressurethat are unique to the cassette.

Still referring to FIG. 18, another feature of the invention providesfor closing off an inflow line or an outflow line with a peristalticpumps 140A or 140B. In one variation, the pump motors 695A and 695B ofthe inflow and outflow pumps 140A and 140B are encoder type motors whichprovide signals to the controller 115 of the rotational position of eachset of rollers on each peristaltic pump. Thus, a controller algorithmcan be provided to stop rotation of a pump roller 696 a or 696 b in avertical position as shown in FIG. 18 which thus pinches the tubing loop442 a and/or 442 b to stop fluid flows through the pinched tubing. Theability of the controller 115 to stop fluid flows mechanically usingencoder motors may be important for maintaining a set pressure or forother purposes. An another example, such encoder motors in a fluidmanagement system 105 can use a controller algorithm that recordsrotations of the inflow pump 140A to thereby determine the fluid volumethat has been delivered through the system. Such a calculated fluidvolume then can be used, in part, to determine fluid deficit. In such avariation, a load cell can be provided to weigh the collected fluidoutflows in the collection reservoir 148 which can be subtracted fromsuch a calculated fluid volume delivered to determine the fluid deficit.

FIG. 19 illustrates another device of the invention which is an opticalsound 700 which is used for an initial step in a hysteroscopy procedure.A conventional uterine sound is standard OB/GYN instrument that is fordilating the cervical canal as well as measuring the length of thecervical canal and the uterine cavity. Such prior are instrumentstypically have graduated centimeter markings for measuring the length ofthe canal or depth of the fundus.

In FIG. 19, the optical sound 700 is adapted for detachable coupling tothe handle component 120 of the endoscopic viewing system 100 of FIGS.1A and 2A-2B. In this variation, the optical sound 700 has a proximalhousing 702 and an elongated shaft 705 that carries an imaging sensor710 and at least one LED 712 in its working end 715. The imaging sensor710 is similar to the sensor 128 and lens 240 system shown in FIGS.6A-7. The optical sound 700 includes electrical connector 718 thatcouples to the receiving connector 180 in handle component 120 (see FIG.3) such that the image sensor 710 cooperates with the endoscopic viewingsystem 100 as described previously. In use, the physician then can thenuse the sound 700 to dilate of the cervical canal under directendoscopic vision and thereafter navigate within the uterine cavity withendoscopic vision. In FIG. 19, the shaft 705 of the sound 700 carriesgraduated centimeter markings 722 and also as a malleable working end715. As can be seen in figure FIG. 19, the proximal housing 702 iswithout features related to a working channel as in the endoscopecomponent 125 of FIGS. 2A-2B.

FIG. 20 illustrates a variation another variation of an optical uterinesound 750 which is similar to that of FIG. 19, except that the opticalsound 750 further includes the inflow and outflow tubing 190A and 190Bshown in FIGS. 1B, 2B and 3 coupled to the sound housing 752 andcooperating inflow and outflow channels 755 a and 755 b in shaft 760.The inflow and outflow channels 755 a and 755 b lead to respectiveinflow and outflow openings 762 a and 762 b in the working end 765(opening 762 a not visible). As can be understood from FIG. 20, theinflow and outflow tubing 190A and 190B are extend from the opticalsound 750 to the fluid management system 105 as shown in FIGS. 1A-1B toprovide fluid flows through the sound. Thus, in one aspect of theinvention, a uterine sound 750 has an elongated shaft with a malleableworking end 765 that carries a distal imaging sensor 710 together withinflow and outflow channels 755 a and 755 b that are connected to afluid management system 105 for providing irrigation inflows andoutflows when the sound is used to dilate a cervical canal and/ormeasure dimensions of a cervical canal or a uterine cavity.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the invention (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. The terms “comprising,” “having,” “including,” and “containing”are to be construed as open-ended terms (i.e., meaning “including, butnot limited to,”) unless otherwise noted. The term “connected” is to beconstrued as partly or wholly contained within, attached to, or joinedtogether, even if there is something intervening. Recitation of rangesof values herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value isincorporated into the specification as if it were individually recitedherein. All methods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any and all examples, or exemplarylanguage (e.g., “such as”) provided herein, is intended merely to betterilluminate embodiments of the invention and does not pose a limitationon the scope of the invention unless otherwise claimed. No language inthe specification should be construed as indicating any non-claimedelement as essential to the practice of the invention.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. An endoscope for use with a tool, the endoscopecomprising: an elongated shaft having a central axis extending from aproximal end to a working end; an image sensor by the working end; achannel extending from said proximal end to said working end, wherein adistal portion of the channel comprises a superior surface spaced froman inferior surface, the inferior surface having a living hinge, whereina lateral sidewall comprising an elastomeric material allows the distalportion of the channel to have a first cross-sectional shape thatprovides an open pathway through the elongated shaft, and whereinadvancement of the tool through the channel and against the superiorsurface and the inferior surface deflects the living hinge withoutdeflecting the tool to expand the channel away from the image sensor toassume a second cross-sectional shape larger than the firstcross-sectional shape such that the image sensor remains stationary uponassuming the second cross-sectional shape.
 2. The endoscope of claim 1,wherein the inferior surface includes a non-elastomeric material.
 3. Theendoscope of claim 2, wherein said distal channel portion in said firstcross-sectional shape maintains a distal open termination by projectingportions of a bottom wall which abut a top wall of said distal channelportion.
 4. The endoscope of claim 1, wherein the elongated shaftextends along a longitudinal axis to an angled section that transitionsto said distal portion that extends along a second axis that is offsetfrom said longitudinal axis.
 5. The endoscope of claim 1, wherein theelongated shaft includes a fluid inflow channel communicating with afluid source.
 6. The endoscope of claim 1, wherein the channelcommunicates with an outflow pump.
 7. The endoscope of claim 1, whereinthe elongated shaft includes a flow channel communicating with apressure sensor carried in a housing coupled to the shaft.
 8. Anendoscope system for use with a tool, the endoscope system comprising: ahandle; an endoscope component including an elongated shaft extendingfrom a proximal housing to a distal section that carries an imagesensor, wherein the proximal housing is adapted for detachable couplingto the handle, wherein the distal section is expandable in a directionaway from the image sensor upon advancement of the tool to assume anexpanded profile while the image sensor remains stationary; wherein theshaft extends along a longitudinal axis to an angled section thattransitions to the distal section that extends along a second axis thatis offset from the longitudinal axis, wherein the angled sectioncomprises a superior surface spaced from an inferior surface, theinferior surface having a living hinge, wherein advancement of the toolagainst the superior surface and the inferior surface deflects theliving hinge without deformation of the tool.
 9. The endoscope system ofclaim 8, wherein the angled section has an axial length ranging from 5mm to 20 mm.
 10. The endoscope system of claim 8, wherein the distalsection has an axial length ranging from 5 mm to 20 mm.
 11. Theendoscope system of claim 8, wherein the second axis is offset from thelongitudinal axis by at least 1 mm.
 12. The endoscope system of claim 8,wherein the second axis is offset from the longitudinal axis by 1 mm to8 mm.
 13. The endoscope system of claim 8, wherein the image sensor anda lens are carried in a housing which has a distal housing surface thatextends distally beyond an outer thin wall sleeve of the shaft.
 14. Theendoscope system of claim 13, wherein said distal housing surfaceextends distally beyond the thin wall sleeve by 0.2 mm to 2.0 mm.